FDA Approves Teva's WELTRUZA for the Treatment of Schizophrenia

Key Facts

The U.S. Food and Drug Administration approved WELTRUZA as the first and only once-monthly subcutaneous injectable olanzapine for adults with schizophrenia. GlobeNewswire reported that Teva Pharmaceuticals announced the approval of the long-acting injectable, which does not require post-injection monitoring or oral supplementation.

The regulatory decision is based on Phase 3 SOLARIS trial results, which demonstrated significant symptom improvement in patients aged 18 to 64. This approval aligns with Teva's 'Pivot to Growth' strategy in neuroscience, addressing common treatment challenges such as nonadherence and the biological risks associated with multiple relapses.